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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Both device classifications were established via the De Novo pathway based on FDA’s review of 2016 and 2017 requests from Ovesco Endoscopy AG and Banyan Biomarkers, respectively. These in turn allow for a device sponsor of a brain trauma assay or an endoscopic electrosurgical clip cutting system to use the 510(k) pathway.

The devices must comply with the specified special controls in order to fall under the new classification as these measures are necessary to mitigate the potential risks to patient health and provide reasonable assurance of safety and effectiveness, according to FDA.

For brain trauma assessment tests, the special controls require developers to use at least one unmodified clinical specimen with the brain injury biomarker for performance testing as well as labeling statements indicating that the test is meant to be used in conjunction with other clinical information. The agency says the special controls are aimed at mitigating the risks of inaccurate test results.

On the endoscopic electrosurgical clip cutting system, FDA says the potential risks include unintended tissue damage and electrical shock. The agency says those risks should be mitigated by nonclinical performance data, usability and electrical safety testing, biocompatibility evaluation and sterilization validation, among other special controls described in the final order.